The Recall Desk
CriticalFDA (Drugs)·D-0250-2015·Announced 2014-11-26

Abrams Royal Pharmacy Recalls Calcium Chloride Injection Due to Sterility Failures

Abrams Royal Pharmacy is recalling 1,100 vials of Calcium Chloride Preservative Free Sterile Injection because contract testing found sterility failures.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Abrams Royal Pharmacy is recalling 1,100 vials of Calcium Chloride Preservative Free Sterile Injection, 100 mg/ml, 10 ml vial, Rx only. The recall is being conducted because the firm's contract testing laboratory found sterility failures in the product.

The affected product is identified by Lot # 05152013@4 (also written as 051513-4) with an expiration date of 11/11/13. The product was distributed to two hospitals in Dallas, TX.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
Affected units
1,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 05152013@4 (also written as 051513-4)
  • Exp 11/11/13

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Abrams Royal Pharmacy

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